The European Medicines Agency on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021
This document is intended to provide guidance to the industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use and should be considered for new marketing authorisation applications, as well as any relevant variation application to existing marketing authorisations.
This guidance also applies to Advanced Therapy Medicinal Products (ATMPs). Where applicable, guidance is provided to include preparation of critical starting materials such as viral vectors and on cell based medicinal products where terminal sterilisation is not possible. For additional specific guidance for Advanced Therapy Medicinal Products, applicants and manufacturers are advised to consult the EC guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs).
Where relevant, the principles of this guideline may also be applied to investigational medicinal products.
This guidance is not intended to cover the water used in situations where medicinal products are prepared extemporaneously or where preparations are reconstituted/diluted with water prior to use by a pharmacist/user (e.g. water for reconstituting oral antibiotic mixtures, water for diluting haemodialysis solutions) or in the case of veterinary products, by the user (e.g. powder for use in drinking water).
This guideline complements the “Questions and answers on production of water for injections by nondistillation methods – reverse osmosis and biofilms and control strategies EMA/INS/GMP/443117/2017 GMP/GDP Inspectors Working Group” which has been published following the implementation of the revised monograph for Water for Injections (0169) and it is intended that the guideline and Q&A should be read together.